Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
NCT ID: NCT02738333
Last Updated: 2018-11-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
239 participants
INTERVENTIONAL
2016-04-12
2017-05-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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LDV/SOF (Cohort 1)
LDV/SOF FDC for 12 weeks
LDV/SOF
90/400 mg FDC tablet administered orally once daily
SOF+RBV (Cohort 1)
SOF+RBV for 12 weeks
SOF
400 mg tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
LDV/SOF (Cohort 2)
Participants who are ineligible for or intolerant to RBV therapy will receive LDV/SOF FDC for 12 weeks.
LDV/SOF
90/400 mg FDC tablet administered orally once daily
Interventions
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LDV/SOF
90/400 mg FDC tablet administered orally once daily
SOF
400 mg tablet administered orally once daily
RBV
Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and \> 80 kg = 1000 mg)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Aged 20 years or older
* Treatment naive or treatment experienced
* At least 20 subjects will have Child-Pugh-A compensated cirrhosis. In Cohort 2, participants must be ineligible or intolerant of RBV.
Exclusion Criteria
* Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
* Pregnant or nursing female or male with pregnant female partner
20 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Bunkyō City, , Japan
Chiba, , Japan
Chūō, , Japan
Ehime, , Japan
Fukuoka, , Japan
Fukuyama, , Japan
Gifu, , Japan
Ibaraki, , Japan
Ikeda, , Japan
Iruma-gun, , Japan
Izunokuni, , Japan
Kagoshima, , Japan
Kashihara, , Japan
Kitakyushu, , Japan
Kumamoto, , Japan
Kyoto, , Japan
Maebashi, , Japan
Matsumoto, , Japan
Morioka, , Japan
Musashino, , Japan
Nagasaki, , Japan
Nagoya, , Japan
Nishinomiya, , Japan
Okayama, , Japan
Osaka, , Japan
Ōgaki, , Japan
Ōmura, , Japan
Saga, , Japan
Sagamihara, , Japan
Sapporo, , Japan
Sendai, , Japan
Suita, , Japan
tabashi City, , Japan
Takamatsu, , Japan
Ube, , Japan
Yamagata, , Japan
Yufu, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol: Original
Document Type: Study Protocol: Amendment 1
Document Type: Study Protocol: Amendment 2
Document Type: Statistical Analysis Plan
Other Identifiers
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GS-US-337-1903
Identifier Type: -
Identifier Source: org_study_id
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